November 2024

For the purposes of this document, the following terms and definitions apply in ethylene oxide sterilization 3.1 Aeration part of […]

Appearance Inspection: Check for any damage on the surfaces of the main machine, control rack, and electrical control cabinet.
Power Supply Check: Ensure the power supply meets the requirements and check the rotation direction of the water pump and vacuum pump.
Turn on the power and observe whether the instrument display values are normal; otherwise, cut off the power, inspect and repair before restarting.
Pipeline Inspection: Check for leaks in the water supply, vacuum, and medication delivery pipelines, and ensure all valves are in standby mode; adjust if necessary.

2.1.1 The overall shape should be precise, with smooth, clean surfaces and uniform color. There should be no burrs, sharp edges, cracks, visible scratches, or unevenness.
2.1.2 All external text, graphics, and symbols must be printed clearly, with precise and durable markings.
2.1.3 Fasteners must be securely installed. All control switches and adjustment knobs (or buttons) should operate smoothly and reliably without obstructions.

Within a certain range of gas concentration, the higher the concentration, the better theEO Gas Sterilization effect; beyond 1000 mg/L, the improvement in sterilization effect is not significant.

eto sterilization technologies vs others: Advantages and Disadvantages Sterilization is a critical process in infection control, ensuring that medical instruments

The temperature setting range of the ETO Sterilization Chamber should be between 30-60°C. It is recommended to perform temperature distribution testing of the sterilizer’s internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.

The purpose of routine monitoring and control of EO (Ethylene Oxide) sterilization is to demonstrate that the confirmed and specified sterilization process has been applied to the product. Data from each sterilization cycle should be recorded and retained to prove that the confirmed sterilization process specifications have been met. This should include at least the following content:

工藝挑戰裝置（ PCD ）係一種微生物挑戰系統，用嚟評估所選工藝參數嘅殺滅率。佢通常係一個包含生物指標（例如已知孢子數量嘅萎縮桿菌孢子）嘅裝置或者測試包。 PCD 對殺菌過程嘅抵抗力應該大於或等於產品最難殺菌嘅區域嘅天然微生物負荷嘅抵抗力。 PCD 嘅數量應該符合 GB18279.1-2015嘅附錄 C 表 C.3所概述嘅要求。 PCD 分為內部 PCD （ IPCD ）同外部 PCD （ EPCD ）。

Industry Eto Sterilizer Installation Verification The installation of Industry Eto Sterilizer and all associated services should comply with the requirements

The humidification water used in the ETO Sterilization Equipment should be free from contaminants, should not weaken the ETO sterilization process, and should not damage the sterilizer, sterilized products, or the load. Humidification should be done by injecting steam, not by directly injecting atomized water.